Query: container closure integrity study methodology
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0076. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-576
Type
deficiency
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-04-08
Status
Draft
Owner
Priya Sharma
Created
2023-12-29
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0076, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_576.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.